2024年9月7日——正在进行的 II 期IDeate-Lung01研究剂量优化阶段发布客观缓解率中期分析数据，评估ifinatamab deruxtecan（I-DXd）1用于既往经治的广泛期小细胞癌（ES-SCLC）患者。该数据在由国际肺癌研究协会主办的2024世界肺癌大会 (#WCLC24) 中以口头报告形式发布。 Ifinatamab deruxtecan是一款采用独有技术设计的潜在首创靶向B7-H3的抗体偶联物（ADC）药物，由第一三共发现，并由第一三共和默沙东合作开发。 Charles M. Rudin 博士 Memorial Sloan Kettering 癌症研究中心 胸部肿瘤科任兼Fiona & Stanley Druckenmiller 肺癌研究中心联席主任 “大多数小细胞肺癌患者接受治疗后病情迅速进展，后线治疗仍存在突出的未满足需求。” IDeate-Lung01是一项全球、多中心、随机、开放标签，两阶段II期研究，以评估ifinatamab deruxtecan治疗ES-SCLC患者的安全性和有效性。该研究分为两个阶段：第一阶段（剂量优化）研究中，患者既

Boehringer is advancing the development of SZN-413 to prepare it for potential future clinical testing SZN-413 is a bi-specific antibody targeting Frizzled Class Receptor 4 (Fzd4) mediated Wingless/Integrated (Wnt) signaling, designed using Surrozen’s SWAP™ technology SZN-413 offers the possibility of restoring retinal function in patients living with retinal vascular diseases Sept. 24, 2024 -- Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN) announced that Boehringer Ingelheim will

An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Oral Simufilam in On-going Phase 3 Trials. The DSMB Recommended Both Phase 3 Trials Continue as Planned, Without Modification. Final Clinical Safety Data for Simufilam Are Expected at the Conclusion of the Phase 3 Program. Sept. 24, 2024 -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced the completion of a third interim

Investigational immunotherapy candidate, VTP-1000, seeks to address significant unmet need in people with celiac disease. An estimated one in 100 people globally suffer from celiac disease, for which no approved treatments currently exist. The first-in-human Phase 1 trial aims to evaluate the safety and tolerability in adults with celiac disease. Sept. 24, 2024 -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidat

Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for a biosimilar candidate to Entyvio® Sales of Entyvio (vedolizumab) were about $5.4 billion globally in the last 12 months up to June 30, 2024 Entyvio is indicated for the treatment of Ulcerative Colitis and Crohn’s disease Sept. 25, 2024 -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide,

小核酸药物是指能利用小干扰RNA（siRNA）、microRNA（简称为miRNA）及反义核酸（ASO）等核酸小分子特异性地沉默疾病基因的表达，以治愈特定疾病的药物，包括ASO、siRNA、aptamer、sgRNA、miRNA等。其具有研发周期短、研发成功率高、特异性强、靶点丰富、效果持久、临床疗效好等优点，有望从源头进行干预，产生"治标治本"的效果，成为继小分子化药、抗体药物后的第三大类型药物。根据相关材料，预计到2025年全球小核酸药物市场将会达到112亿美元。国际上涌现了Ionis、Alnylam、Sarepta三巨头，诺华、礼来、诺和诺德、BMS等MNC纷纷投入巨资进入该领域。例如：2024年9月4日，礼来与核酸药物平台公司HAYA达成合作，后者是是一家开创性采用精准RNA引导的调控基因组靶向治疗慢性疾病的生物技术公司，双方将针对肥胖及相关代谢疾病开展临床前药物发现工作。不久前礼来刚宣布斥资7亿美金在波士顿创立核酸药物研发中心。 相较于以前小核酸药物主要用于罕见病，近年来小核酸药物越来越多用于慢性病、常见心血管疾病领域，其安全性必将是越来越受到重视的问题。本文以研发进度领先

September 23, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that the European Commission has conditionally approved Iqirvo®1 (elafibranor) 80mg tablets for the treatment of Primary Biliary Cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA

优时比（UCB）今天宣布，美国FDA已批准Bimzelx（bimekizumab）用于治疗活动性银屑病关节炎（PsA）、有客观炎症迹象的活动性非放射性中轴脊柱关节炎（nr-axSpA）以及活动性强直性脊柱炎（AS）成人患者。根据新闻稿，Bimzelx是美国FDA批准用于治疗四种慢性免疫介导炎性疾病的首个白介素-17 A/F（IL-17A/F）抑制剂。行业媒体Fierce Biotech称Bimzelx具有成为潜在重磅药物的潜力。 Bimzelx获批用于治疗活动性PsA成人患者，主要是基于3期BE OPTIMAL和BE COMPLETE研究的数据。分析显示，与安慰剂相比，Bimzelx在第16周时达到了美国风湿病学会50（ACR50）应答的主要终点，以及其他次要终点。在生物制品初治患者和TNF抑制剂应答不足（TNFi-IR）患者中均观察到了一致的结果。在对BE OPTIMAL和BE COMPLETE及其开放标签扩展研究的分析显示，患者在第16周实现的临床应答可持续至第52周，评估标准包含ACR50（主要终点）、银屑病面积和严重程度指数90（PASI90，次要终点）、最小疾病活动度（MD

Recommendation based on a Phase 3 trial showing a significantly greater proportion of children on Dupixent achieved histological remission compared to placebo, consistent with improvements seen in adults and adolescents If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group Sept. 20, 2024 --- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for Medicinal Products for Human U

9月23日，四川百利天恒药业发布公告，公司于近日收到国家药监局正式批准签发的《药物临床试验批准通知书》，同意其自主研发的创新生物药多特异性抗体GNC-077开展晚期实体瘤的临床试验。 据公告披露，GNC-077是百利天恒自主研发的一种创新的多特异性抗体分子，其分子结构包括靶向T细胞CD3和T细胞免疫检查点的抗体结构域，以及靶向肿瘤抗原的抗体结构域。GNC-077可有效诱导T细胞的活化、分化及增殖，并介导活化的T细胞特异性靶向杀伤肿瘤抗原阳性的肿瘤细胞。 在体内研究中，GNC-077已在多种实体瘤中显示出强大的抗肿瘤疗效。 内容来源于网络，如有侵权，请联系删除。